Diabetes mellitus, often referred to simply as diabetes, encompasses a variety of conditions that involve disordered metabolism, the typical feature of which is abnormally high blood sugar levels (hyperglycemia). Blood sugar levels are controlled by a complex network of chemicals and hormones in the human body, including the hormone, insulin, produced by the beta cells of the pancreas. The abnormally high level of blood sugar seen in a diabetic patient is caused by defects in either insulin secretion or insulin action, attributable to a combination of hereditary, acquired, and environmental factors. Majority of diabetes are either type 1 diabetes, previously known as childhood-onset diabetes and insulin-dependent diabetes, or type 2 diabetes, previously known as adult-onset diabetes and insulin-independent diabetes.
Type 1 diabetes is characterized by loss of the insulin-producing beta cells of the islets of Langerhans in the pancreas, resulting in a deficiency of insulin production. The principal treatment for this type of diabetes is therefore delivery of artificial insulin, usually via injection. Type 2 diabetes is more common than type 1 diabetes with over 90% of affected people having type 2 diabetes. The latter is closely associated with modernization characterized by obesity and insulin resistance (reduced insulin sensitivity) although diminished insulin production is needed for development of overt hyperglycemia. Both twin and family studies support a strong genetic component for type 2 diabetes. Recent genetic implicate multiple common genetic variants in the development of type 2 diabetes although these factors only explained a small percentage of the variance of the genetic risk of type 2 diabetes.
Various factors are known to be indicative of a person's risk to develop type 2 diabetes, most of them strongly influenced by the person's lifestyle, age, ethnic background, and family history. The presence of at least one, often more, of these risk factors, such as a body mass index (BMI) in the range of obesity (especially central obesity due to accumulation of excess visceral fat as indicated by large waist circumference), elevated blood glucose or insulin level (especially elevated fasting or post prandial blood glucose or insulin level), and reduced sensitivity to insulin, predisposes a person to the high likelihood of developing type 2 diabetes, if no corrective measure is taken.
As people's living standards continue to improve globally, the number of individuals suffering from diabetes is also rapidly increasing. The World Health Organization (WHO) estimates that by 2030 the number of people living with diabetes will exceed 350 million worldwide. At the present time, an estimated 35% of all US adults and 50% of those aged 60 years or older have metabolic syndrome, a cluster of pre-diabetic conditions including increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels, which occur together can lead to significantly increased risk of heart disease, stroke, and diabetes. In addition, it is now known that diabetes increases risk of cancers of all sites by 30% except for prostatic cancer. Due to the rising incidence of diabetes, its chronic nature without an ultimate cure, and serious health implications associated with its complications, including but not limited to cardiovascular disease, kidney failure, cancer, blindness, leg amputation, which collectively carry enormous social and economic impact in a global scale, there exists an urgent need for new and effective means for treating and managing diabetes and associated diseases. The present invention fulfills this and other related needs.